levoketoconazole
Trade name: Recorlev
Small moleculeapprovedOrphan Drug FDA
Approved
Dec 30, 2021
Clinical trial activity
0 trials · 0 clinical orgs · 2 marketing orgs
Phase 1
0
Phase 2
0
Phase 3
0
Phase 4
0
Timeline
2010s
- Mar 9, 2012
Orphan Drug Designation
2020s
- Dec 30, 2021
Xeris Pharmaceuticals — Earliest FDA Approval
- Dec 30, 2021
Strongbridge Biopharma — Marketing Organization
- Dec 30, 2021
Xeris Pharmaceuticals — NDA Secondary Org
- Dec 30, 2021
Xeris Pharmaceuticals — NDA Organization
Indications
Approved for
Mechanism of action
- Cytochrome P450 11BANTAGONIST
Cytochrome P450 11B antagonist
Approval history
- approvedDec 30, 2021
Chemistry & pharmacology
Oral
No
Parenteral
No
Topical
No
Organizations
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Strongbridge Biopharma | For profit | MKTG | Dec 30, 2021 |
| Strongbridge Biopharma | For profit | SYN | Dec 30, 2021 |
| Xeris Pharmaceuticals | For profit | NDA2 | Dec 30, 2021 |
| Xeris Pharmaceuticals | For profit | NDA | Dec 30, 2021 |